End-diastolic pneumatic compression has been investigated in the treatment of peripheral vascular disease, venous stasis, and lymphedema. Timed, sequential inflation during the end-diastolic portion of the cardiac cycle is applied to a boot enclosing the foot or ankle, or extending from the toes to the groin, and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic fluid (e.g. The Circulator Boot™, Multicrus Circulator Boot™). Therapy is typically offered in a series of 40-minute sessions in an office setting.
The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the electrocardiogram (EKG) and to appropriately time boot compressions in the end portion of the heart cycle; a rapid action valve assembly capable of both pressurizing and exhausting the boots; rigid, adjustable long boots to enclose the leg from groin to toes; and double-walled plastic bags to enclose the treated portion of the leg and to contain the compressed air.
The end-diastolic compression device is distinctly different from single and multi-chambered lymphedema devices (used in the presence of significant lymphedema) and intermittent compression pumps (used for DVT prevention). The latter 2 devices do not require synchronization with the cardiac cycle whereas the end diastolic pump relies on EKG input to apply timed compression just prior to the next QRS complex thereby reducing afterload and cardiac work. This same synchronized compression technology is used under direct supervision by a physician to increase in cardiac output; and in that setting is known as enhanced external counterpulsation.
NOTE: Lymphedema devices, intermittent compression pumps and enhanced external counterpulsation intended to treat decreased cardiac output are NOT addressed by this policy.
End-diastolic pneumatic compression boots for the treatment of vascular diseases and related conditions, including but not limited to lymphedema, claudication pain, venous stasis ulcers, and ischemic lesions are considered investigational.
See also: Pneumatic Compression Pumps for the Treatment of Lymphedema, DVT Prophylaxis and Venous Ulcers in the Home Setting
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Well-designed studies, which evaluate the clinical importance of end-diastolic pneumatic compression devices for the treatment of vascular disease and related conditions, continue to be lacking. The available evidence is small case series which are outdated, and no randomized controlled trials are available regarding this technology. Therefore, the technology is considered investigational.
Alvarez, O., Wendelken, M., Markowitz, L. and Comfort, C. (2015, November) Effect of high-pressure, intermittent pneumatic compression for the treatment of peripheral arterial disease and critical limb ischemia in patients without a surgical option. Wounds, 27 (11),293-301. Abstract retrieved July 25, 2017 from PubMed database.
Berliner, E., Ozbilgin, B., and Zarin, D., (2003) A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers. Journal of Vascular Surgery, 37, 539-44. (Level 2 evidence)
Buschmann, E., Brix, M., Li, L., Doreen, J., Zietzer, A., Li, M., et. al. (2016) Adaptation of external counterpulsation based on individual shear rate therapy improves endothelial function and claudication distance in peripheral artery disease. Vasa (European Journal of Vascular Medicine), 45 (4), 317-24. Abstract retrieved July 25, 2017 from PubMed database.
First Coast Service Options, Inc. (2017, July) Local Coverage Determination (LCD): Non-covered Services (L33777) Retrieved July 25, 2017 from https://www.cms.gov.
U. S. Food and Drug Administration (2005, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K042217. Retrieved April 18, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration (2007, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072666. Retrieved April 18, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K020857. Retrieved December 5, 2012 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082134. Retrieved April 18, 2011 from http://www.accessdata.fda.gov.
Winifred S. Hayes Medical Technology Directory (2013, July, last update search June 2017) Intermittent pneumatic compression for peripheral arterial disease. Retrieved July 25, 2017 from www.hayesinc.com (47 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 9/14/2017
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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